Treatment (Compassionate) Use of Device - PK Papyrus
- Conditions
- Pseudoaneurysm, CarotidPseudoaneurysm
- Registration Number
- NCT05436470
- Lead Sponsor
- University of Miami
- Brief Summary
The purpose of this study is to evaluate the clinical use of the PK Papyrus Coronary Stent Graft System, a Humanitarian Use Device (HUD) approved by the FDA under a Humanitarian Device Exemption.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TEMPORARILY_NOT_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Patients with traumatic, dissecting, pseudo, or other wide based aneurysms in non-perforator territories or fistulas of the extracranial or intracranial segments of the internal carotid or vertebral artery.
Exclusion Criteria
- Patients from special populations including individuals who are not yet adults (infants, children, teenagers).
- Adults who are cognitively impaired, pregnant women, and prisoners.
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the clinical outcomes of the PK Papyrus Coronary Stent Graft System in treating carotid pseudoaneurysms compared to endovascular coiling?
What molecular mechanisms underlie the efficacy of coronary stent graft systems in pseudoaneurysm wall stabilization and thrombosis induction?
Which biomarkers correlate with successful exclusion of pseudoaneurysm sacs using the PK Papyrus device in compassionate use scenarios?
What adverse events are associated with the PK Papyrus Coronary Stent Graft System in carotid artery interventions and how are they managed?
How does the PK Papyrus device compare to other FDA-approved humanitarian use devices for carotid pseudoaneurysm treatment in terms of safety and efficacy?
Trial Locations
- Locations (1)
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Jackson Memorial Hospital🇺🇸Miami, Florida, United States